AngioSystems Drape 3000-06

by Angiosystems, Incorporated

AngioSystems Drape 3000-06 is a Class II device made by Angiosystems, Incorporated, cleared under FDA 510(k) K843260 on 21 Sep 1984 and listed in FDA GUDID since 26 Mar 2021 (UDI-DI 00816611025659), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00816611025659 UDI-DI	Date26 Mar 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK843260	Date21 Sep 1984Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00816611025659
FDA 510(k) database 510(k) number K843260

Across registries

2 registries list this device

FDA 510(k) K843260 decided 21 Sep 1984 Active
FDA GUDID UDI-DI 00816611025659 listed 26 Mar 2021 Listed

Timeline

2 dated events

21 Sep 1984 Cleared FDA 510(k) K843260
26 Mar 2021 Listed FDA GUDID 00816611025659

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: AngioSystems Drape
Generic name: Patient surgical drape, single-use
Model / reference: 3000-06

Primary DI / UDI-DI: 00816611025659
510(k) Number: K843260
FDA product code: KKX
GMDN term: Patient surgical drape, single-use

Device class: Class II
Regulation number: 878.4370
GUDID distribution status: In Commercial Distribution

Other devices from Angiosystems, Incorporated

See all devices from Angiosystems, Incorporated →

Properties

Supplied sterile
Single use
Lot / batch number
Expiration date

Other properties (11, all answered No)